Improving Patient Safety Through Simulation Research

Improving Patient Safety Through Simulation Research: Airway Management Proficiency Study

The overall objective of the present proposal is to assess whether medical simulation can enhance the safety and proficiency profile of paramedics performing prehospital endotracheal intubation, and whether feedback from an airway management expert observing the simulation enhances skill retention after 12 and 24 months. Since no validated proficiency assessment tool currently exists to measure the skill of paramedics in airway management, one will be developed and tested. Using this tool, 250 paramedics in central Ohio, will undergo simulation training similar to that required for certification. A baseline assessment of proficiency will be obtained. One group will be randomized to receive simulation training similar to that required for certification, while the other group will receive feedback from an airway management expert linked to the simulation test site via a 2-way audio-video feed. Both groups of paramedics will be reassessed at 12, and 24 months to determine whether skill level was maintained or whether skills deteriorated, and whether expert intervention had any impact on skill retention.

Study Overview

• Status: Completed
• Conditions: Airway Management Assessment
• Intervention / Treatment: Other: Directed feedback; Other: Basic Videolaryngoscopy Videos

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently certified central Ohio paramedics

Exclusion Criteria:

• Refusal to participate
• Non-certified paramedics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Simulation only; One group will be randomized to receive simulation training similar to that required for certification. Paramedics in this group will then complete a second simulation scenario
Experimental: Directed feedback; One group will review their baseline simulation scenario with a member of the research staff while providing specific feedback for errors made during the first simulation. Paramedics in this group will then complete a second simulation scenario.	Other: Directed feedback; Group will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video
Experimental: Basic Videolaryngoscopy; One group will review a series of instructional videos related to common airway management errors. Paramedics in this group will then complete a second simulation scenario.	Other: Basic Videolaryngoscopy Videos; Group will watch a series of educational videos related to common airway management errors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development and validation of an airway management assessment tool	Employing a team of psychometric, human factors, and airway management experts, we propose to make refinements to our assessment tool so that it has objective measurement criteria, takes timing and sequencing of actions into account, provides reproducible scores, has high inter-rater reliability, and can be a valid measure of paramedic airway management proficiency and safety.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of educational interventions to improve skill retention	The paramedics will be reassessed at 12 to determine whether skill level was maintained.	2 years

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Thomas E Terndrup, MD, The Ohio State University Wexner Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Airway Management; Intubation; Simulation; Proficiency; Enhance; Paramedics.
• Other Study ID Numbers: 2013H0226